School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

University of Pittsburgh

Status: Invitation-only

Conditions: Type 1 Diabetes

Treatments: Behavioral: Enhanced usual care; Behavioral: SPACE for T1D

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06420661

STUDY23120069

K23DK135800 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

Full description

This pilot cluster randomized controlled trial will examine the feasibility of a school-partnered collaborative care (SPACE) model for children with type 1 diabetes (SPACE for T1D). School districts will be randomized to the intervention or control arm in a 2:1 allocation ratio. School districts randomized to the control arm in Year 1 of the study will be invited to participate in SPACE in Year 2. All children with type 1 diabetes meeting inclusion criteria in each school district will be approached to participate through their school nurse.

All research activities will be conducted using a virtual video-conferencing platform. The intervention arm will consist of four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and any other identified school-related support people. The purpose of these meetings will be to determine a shared treatment plan, make treatment recommendations, and determine progress towards meeting the child's goals. The control arm will receive usual care in the school and the clinical setting as well as monthly phone calls from the DCES to the parent to offer review of blood glucoses. No additional contact with the school will be offered.

Participants and their parents will be asked to complete surveys regarding their overall health and well-being and provide us access to their glucometer/continuous glucose monitor data. Additional information will be collected from the electronic health record (hemoglobin A1c, care utilization, referrals). At the end of study, surveys for the parent and school nurse will assess feasibility and other implementation outcomes.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 1 diabetes for at least 6 months
• Attend school in one of the partnered school districts
• Receive daily oversight from the school nurse for their diabetes
• Managed by the Children's Hospital of Pittsburgh Diabetes center
• Able to participate in English

Exclusion criteria

• Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
• Child is completely independent in diabetes care in school

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SPACE Intervention

Experimental group

Description:

The intervention consists of four monthly virtual visits between the school nurse, diabetes care and education specialist (DCES), parent, and any other school-related supports identified by the parent (e.g., coaches, counselors, social workers). At the first visit, the parent and child, school nurse, and DCES will discuss and determine a shared treatment plan. This will include a diabetes medical management plan and shared treatment goals for the child. At each virtual visit, the DCES and school nurse will co-lead the group through review of the shared treatment plan, a review of glucose records and insulin dosing for diabetes management, provide counseling/education, and identify any needed internal (academic) or external (health-related) supports or referrals. Families will be encouraged to set new treatment goals if any milestones are met.

Treatment:

Behavioral: SPACE for T1D

Control

Active Comparator group

Description:

In addition to usual care (clinical and in school), parents of children enrolled in the control group will receive four monthly phone calls from the DCES to review diabetes management, mirroring the timing of the virtual visits of the intervention group. This study will employ a wait list control.

Treatment:

Behavioral: Enhanced usual care